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Report: Approval for One Neuropathic Pain Indication Supports Prescribing and Reimbursement Across Multiple Populations

Improved safety and tolerability is key consideration (May 28)

Decision Resources, a research and advisory firm based in Burlington, Mass., finds that expanded labeling for additional neuropathic pain (NP) populations and/or broader NP labeling (peripheral NP) will not ensure increased physician prescribing or improved formulary coverage.

Instead, the survey’s findings show that primary care physicians, pain specialists, and neurologists are comfortable prescribing NP therapies to an array of NP populations for which the agents are not specifically labeled. Moreover, the majority of surveyed directors of managed care organizations (MCOs) indicated that they will reimburse these therapies for any form of NP, at the physician’s discretion.

“Most surveyed payers recognize the difficulty in treating NP and agree that reimbursement for NP will be less restrictive than reimbursement for other forms of chronic pain,” said analyst Andrea Buurma. “However, newer agents like Depomed’s Gralise and XenoPort’s Horizant face more restrictive coverage on surveyed payers’ commercial plans and Medicare prescription drug plans, likely because these agents’ parent molecule, gabapentin, is available generically and has widespread, favorable formulary coverage.”

The survey also finds that safety and/or tolerability advantages could positively influence formulary decisions owing to subsequent improvements in patients’ quality of life, thereby offsetting downstream health care costs. However, emerging therapies that are reformulations of available molecules — and that offer limited advantages beyond improved delivery — will likely face significant market access hurdles, particularly if priced at a premium to their parent molecules. According to the new report, MCOs have largely excluded, unfavorably tiered, or attached prior authorization and/or step therapy protocols to Gralise and Horizant — gabapentin reformulations that offer less frequent dosing than generic gabapentin.

Further, the findings reveal that the ability of Nucynta ER (tapentadol, Janssen) to reduce pain intensity is the primary factor driving its use for NP among surveyed physicians who currently prescribe or plan to prescribe the drug.

Although Nucynta ER is approved for only one NP indication — painful diabetic neuropathy — many surveyed physicians report that they prescribe or will prescribe the drug to patients with other forms of NP, such as neuropathic back pain. However, the findings indicate that Nucynta ER is and will be largely reserved as a second-line or later therapy, likely resulting from its schedule II status; from the entrenchment of early-line therapies, such as gabapentin, Lyrica (pregabalin, Pfizer), and Cymbalta (duloxetine, Eli Lilly); and from step therapy and prior authorization requirements instituted by surveyed MCO directors.

Source: Decision Resources; May 28, 2013.

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